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Life science

If you do not want the success of your company to rely on the next break-through innovation only, you need to focus on operational excellence – starting with your supply chain.
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Unleashing the potential of your operations and supply chain is key to winning tomorrow

We help you towards excellence in operations and supply chain management.

Working in a global life science company, your organisation is likely to be R&D and/or compliance driven. But by zooming in on the operations and supply chain, you will often find a huge unused potential directly impacting your capacity, lead times and EBIT.

Succeeding within life sciences is different from any other industry. It requires effectiveness in deviation handling, robust processes and a management team across all levels capable of ensuring efficient flows in key functions such as QC and QA. At Implement, we understand the unique industry requirements and how to achieve operational excellence in a highly constrained environment.

We house more than 100 consultants specialised in the life science industry operating out of the Nordics, Switzerland, Germany and the US. Ranging from procurement to manufacturing and from warehouse management to distribution, we have expertise covering the full value chain to help life science companies optimise their operations while ensuring profitability.

Our clients range from global industry leaders to agile newcomers embarking on impressive growth journeys. Whatever your current maturity level, we can help you on the transformation towards best practice. A transformation that often requires life science companies to excel within three strategic areas:

Keeping margins competitive

To stay competitive in pharma and medtech, it is key that you have an explicit focus on costs throughout your value chain.

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Designing for robustness

​Designing robust processes is a prerequisite to ensure high process performance, stability in production and increased efficiencies.

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Setting at digital agenda

Navigating through the seemingly endless opportunities and balance your visionary ideas with your business needs.

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Keep margins competitive

To stay competitive in pharma and medtech, it is key that you have an explicit focus on costs throughout your value chain – especially when operating in an industry characterised by high R&D costs, long time to market, heavily regulated pricing, constraining regulations and increased pressure from payers.

To protect your margins, you need to adopt a holistic view of your E2E supply chain and to critically assess your operations. 

For medtech and pharma companies, finding efficiencies in operations can take many forms, depending on the specific challenges of your company. However, we find that companies in these sectors often benefit from targeting three distinct areas:

Operating system

If you want to achieve operational excellence, an essential foundation is that you have a well-functioning operating system, and if you work within the life science industry, improving on quality helps you stay competitive by reducing costs of continuous deviation handling and scrapping of batches.

Working with you, we evaluate the existing structures, processes and tools constituting the foundation of your operating system. 

When we assist you in designing a solid operating system in pharma and medtech, we include elements such as deviations/incident management, batch release and validation. We are experienced from working with global industry leaders and are specialised in designing a new operating model fit for both your organisation and the people working in it. 

Process improvement

One of your most important levers to maintain cost control is process improvements, and for companies within pharma and medtech, productivity gains are often achievable for both equipment and people. 
We can help you:

  • Improve OEE on critical equipment throughout the supply chain to a world-class level, which will both improve your throughput as well as avoid/postpone CAPEX in new plants, lines, equipment and hires.
  • Target the biggest potential: often, focus is on making shop floor processes more efficient by optimising processes around operators. But we also work with you on improving the “paper” processes supporting the production to obtain a more balanced ratio between blue and white collar as it is our experience that the biggest potential often lies here.

Supply chain optimisation 

Optimising your E2E supply chain to avoid initiatives negatively impacting your value proposition, it is key that you take a customer perspective. 

We can support you in how you use optimisation levers that pharma and medtech companies can often use without compromising customer services, including: 

  • Rethinking your strategy for inventory management, including adaption of a multi-echelon approach, better cross-functional coordination and a review of underlying planning parameters with special focus on lead time to lower inventory, reduce scrap and improve customer service.
  • Reviewing your distribution strategy based on patient needs. Many distribution networks can be a patchwork built over several years, challenging GDPR compliance. We help you assess your channel design, updating the setup to be reliable and thereby reducing costs.
  • Strengthening your portfolio through integrations/carve-outs. Selling and buying products to optimise your product portfolio has become the norm in today’s business. We assist you in building the critical competencies to handle these transactions without jeopardising customer service by enabling you to efficiently carve out or integrate products, sites/production lines/CMOs/distributors and to handle the regulatory changes and building up transition stock in order.

Cases

Improving quality assurance efficiency at a pharma market leader​

Case

Improving quality assurance efficiency through structured operations management specially tailored for pharma and quality assurance establishing a strong focus on standardised tasks and daily prioritization.

Helping pharma pioneer build a world class quality control department ​

Case

Building a world class quality control department. Key project activities included Gemba in laboratories/chemist offices, co-creation of solutions through Kaizen Blitz, process optimisation, 5S, visual boards, board meetings and planning principles of the lab technician/chemist work.

Developing a supplier strategy for a medical equipment manufacturer

Case

Operating model design and KPI development and development of a supplier strategy for Injection Moulding organisation in order to enhance the cooperation with suppliers.

Questions?

Please reach out to one of our experts on keeping margins competitive:

Design for robustness

​Designing robust processes is a prerequisite if you are looking to ensure high process performance, stability in production and increased efficiencies.

​Typically, life science companies spend much time handling issues as they occur. A deviation is raised, investigations occur, and within 30 days, the problem is hopefully solved, and a CAPA (corrective and preventive action) is created.

​But instead of handling issues as they occur, your company can benefit greatly from turning things around and putting the preventive action first: a PACA approach. This requires a change of mindset towards preventing disruptions everywhere in the organisation before a deviation is ever raised.

​We can help you foster a robustness mindset where focus is on avoiding disruptions such as deviations – this not only helps you to create more stable processes but eventually also reduces unit costs e.g. by minimising scrapping risk and freeing up resources.

From CAPA to PACA

Turning away from the traditional CAPA approach acting purely reactively, life science companies can improve significantly by focusing on spotting and avoiding incidents that could happen.

We can support your organisation’s transition towards a PACA mindset where preventive actions are considered a challenge, requiring several aspects to come together:

  • Implementing a change of mindset and culture to ensure that key stakeholders are encouraged and have the time to critically assess and question existing processes.
  • Establishing a performance measurement system that shifts from solely rewarding timely deviation handling to focusing on process improvements, root cause investigation and proactive thinking.
  • Creating an organisational setup that distributes decision power to the stakeholders actually involved in the key activities of the day-to-day-business.
  • Introducing a sprint-based approach where solutions are designed for rapid testing and adjustments before scaling.

Succeeding in transitioning your organisation towards a PACA approach, you will get a continuous flow of ideas and a more balanced approach to continuous improvements where the right people with the right competencies are engaged and involved in identifying, prioritising and solving the most critical tasks.

Optimising towards instant batch release

It is essential that you improve your processes supporting the release of batches when you aim to minimise consequences and delays of deviations.

We can support you in reducing the number of deviations and the likelihood of losing a batch by helping you establish the necessary processes allowing your organisation to work structurally with problem-solving, addressing potential root causes and testing (and implementing) robust solutions.

You may see instant batch release as not immediately realisable and only as a long-term target. But despite of maturity level, most pharma and medtech companies benefit from starting the journey targeting instant batch release and can utilise the incremental steps to obtain increased process control, reduction of incidents and better availability of the right data.

We recommend starting out by identifying and prioritising the appropriate incremental steps based on an understanding of your company’s current maturity, including:

  • Execution ability – amount and character of incidents during release
  • Digitalisation – availability and use of digital solutions to support releases
  • Process stability – overview and control of critical parameters
  • Simplicity in review and release process – balancing requirements to avoid over-processing
  • Real-time test results – streamlined sample, test and review processes
  • Leadership and culture – support of preventive mindset and time to investigate for root causes

Cases

Accelerating systematic problem solving in pharmaceutical production​

Case

Through intensive training and coaching, managers and key employees increased their ability to respond to variation and errors through GEMBA walks, employee-driven problem-solving and process confirmation of solutions. To make the journey concrete, a maturity model and subsequent ambition was co-created together with managers. 

Developing a strategic maturity model for Instant Batch release

Case

Helping a pharmaceutical company​ develop a strategic maturity model for Instant Batch release by facilitating the development of a maturity model that spots cross-functional challenges and strengthens the local ability to local improvements.

Questions?

Please reach out to one of our experts on designing for robustness:

Set a digital agenda

Regardless of your starting point, we can help you identify, plan and implement the next steps on your journey towards digitisation – whether small, incremental steps or massive digital transformations.

Should your manufacturing site be fully automated? Do you need driverless vehicles as a part of your distribution setup? What would it take to implement instant release of batches?

The digital opportunities for improving and optimising your businesses are continuously developing, and the landscape of revolutionary digital solutions is expanding rapidly. We can help you navigate through the seemingly endless opportunities and balance your visionary ideas with your business needs. We can guide you along well-tested solutions available with great potential for companies ready to embark on the journey towards a more digital future.

Maturity assessment

Understanding your baseline is critical when planning the next steps of your organisation’s digital journey. Sites, and even departments, are at different maturity levels, so what is the I4.0 maturity of your current setup? What are your specific key levers to drive digitalisation to the next level in your organisation?

We help you set the right goals – not too ambitious though, as you then risk losing your employees’ and management’s support in the process. But also not too unambitious, as you then end up with unrealised potential. In setting the right goals, we support you in ensuring the vital first step of any digital transformation: that your key stakeholders and users are on board.

To strike the right balance between ambition and organisational readiness, we recommend you to initiate a maturity assessment. This will help you define the current state of your pharma or medtech company and provide you with an indication of actions you need to take to move up the maturity ladder.

Working with you, we would apply a holistic assessment, including critical review of:

  • Automation in manufacturing, transport and pick-and-pack processes
  • Online quality systems and automation of trivial admin tasks
  • Real-time visual shop floor execution and re-scheduling of orders to optimise capacity
  • Preventive to predictive maintenance based on data supporting detection of anomalies
  • Supply chain connectivity across sites, suppliers and customers

Road map towards I4.0

Knowing your starting point and organisational maturity sets the foundation for your digital transformation. Now, you must identify, prioritise and initiate the next steps of your digital journey.

We can help you create a clear vision of what the final destination of your digital journey looks like – and the road ahead – by creating a digital road map towards Industry 4.0. Based on the road map, you can define the digital future state of your organisation and choose amongst the paths towards I4.0.

More than just identifying the digital solutions available, we help you create a road map that is a full assessment taking into account the strategic fit, financial implications and current maturity level of your organisation with the aim of detecting and prioritising initiatives and planning for the transition towards a more digital future.

Design for automation and machine learning

Automation of trivial, repetitive tasks is a way to not only increase efficiency and eliminate the risk of human errors – it is also a way to attract and retain valuable resources.

We can help you implement software robots to perform repetitive tasks. This enables you not only to free up valuable time but also create potential for scaling by establishing a new function responsible for automating new processes. We can help you train your freed-up resources to manage these new responsibilities, which will enable you to not only make better use of your resources but also have a positive impact on retention rates.

The area of designing software robots capable of automating tasks or adding machine learning elements to ensure existing processes is continuously improved and refined. We follow the development and can help you apply these efficient ways to both increase performance and ensure that human resources are utilised for the right tasks.

Cases

Automating the material review process for a pharma market leader​

Case

Documenting, optimising, and automating the material review process. Also integrating a machine learning algorithm into the automation enabling the initial automation steps to continuously present the most relevant values to the user.

Helping a global pharma company establish a new RPA platform​

Case

Establishing a new RPA platform by utilising a strong and well-developed methodology. Establishing an organisation for rolling out RPA across the company, including RPA IT infrastructure, RPA operational model, RPA competency building and automated processes.

Helping a biotech company automate their sample cloning flow ​

Case

Automating the sample cloning flow. Determining the benefits of automating the cloning flow and how to design such a flow in order to introduce a new automated cloning robot and generate R&D process improvements.

Questions?

Please reach out to one of our experts on setting a digital agenda:

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